- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00108160
Preventing Staphylococcal (Staph) Infection
March 20, 2014 updated by: US Department of Veterans Affairs
Intermittent Mupirocin to Prevent Staphylococcal Infection
The purpose of this study is to determine if mupirocin 2% in polyethylene glycol (PEG) ointment [Treatment Arm] is effective in preventing moderate to severe re-infection with Staphylococcus aureus compared with treatment with polyethylene glycol (PEG) ointment [Placebo Arm].
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Treatment of staphylococcal carriage with the topical antibiotic, mupirocin, has led to decreased infections in some hemodialysis patients and intensive care unit (ICU) patients.
However, most of these studies were not placebo controlled and only certain subsets of patients benefited.
Relapse of colonization, generally within 90 days after treatment is stopped, presumably with increased risk of infection, approaches 50%.
Continuous use of mupirocin on daily, three times weekly, or weekly basis has resulted in increased resistance to the drug.
Despite this lack of evidence, the use of mupirocin has become commonplace because it is perceived as an effective and simple means to prevent infection.
In a National Institutes on Aging/Claude D. Pepper Older Americans Independence Center (NIA/OAIC)-sponsored proposal, we found that a 2 week treatment regimen with mupirocin ointment was effective in decolonizing older chronically ill nursing home residents of S. aureus when compared with placebo ointment.
Decolonization began to decline by 3 months post-treatment, and resistance occurred only once in 52 treated patients.
That study was not powered to detect differences in infection between the 2 study groups; the end point was eradication of colonization.
However, a trend towards reduction in staphylococcal infection with mupirocin was seen.
In addition, there were more therapeutic failures in residents who were colonized with methicillin-resistant S. aureus (MRSA) than methicillin-sensitive S. aureus (MSSA).
We hypothesize that intermittent treatment with mupirocin ointment every 3 months may be an effective means of preventing recolonization and infection with S. aureus.
We propose to study a patient population that has already had treatment for severe S. aureus infection and is at significant risk for a subsequent infection.
Patients will receive mupirocin 2% polyethylene glycol (PEG) ointment [Treatment Arm] or polyethylene glycol (PEG) ointment [Placebo Arm] for 14 days every 3 months.
The effect of these two regimens on S. aureus re-infection, re-colonization, and development of mupirocin resistance will be assessed.
Study Type
Interventional
Enrollment (Actual)
146
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
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Ann Arbor, Michigan, United States, 48113
- VA Ann Arbor Healthcare System
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients who receive care at Ann Arbor VA Medical Center, University of Michigan Medical Center, or St. Joseph Mercy Hospital, Ypsilanti who have been hospitalized for documented S. aureus infection will be eligible for enrollment. Staphylococcal infections may be community or hospital-acquired. Patients with S. aureus infection will be identified on a daily basis with the assistance of the Infection Control Practitioner, the Clinical Microbiology Laboratory, the Infectious Diseases Consultation Services, and Infectious Diseases physicians caring for patients in their offices.
- Patients will provide written informed consent. The patient's guardian or next of kin will be contacted for informed consent in the event that the patient is incapable of doing so.
Exclusion Criteria:
- Patients who are unable to cooperate with treatment or follow-up.
- Patients who are not likely to survive beyond one month or those who are transferred back to another acute care hospital.
- Patients who require treatment with rifampin will be excluded since this drug is effective in decolonization of some staphylococcal carriers.
- Patients with known hypersensitivity to mupirocin ointment or polyethylene glycol base.
- Patients with ulcers obviously related to pressure will be excluded because they are frequently large, difficult to keep clean, and infections are difficult to diagnose.
- Patients with small vascular or neuropathic ulcers < 3 cm in circumference and < 2 cm in depth may be enrolled.
- Pregnant women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mupirocin Ointment [Treatment]
Treatment arm or active comparator [mupirocin 2% polyethylene glycol (PEG) ointment] will be compared with its placebo comparator [polyethylene glycol (PEF) in patients with a prior history of S. aureus infection.
Drug or placebo will be applied topically to nares and/or wounds twice daily for 14 days at 3 month intervals for up to 18 months
|
The impact of the treatment arm versus placebo arm on development of new (recurrent) S. aureus infection will be assessed as the primary end point.
Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.
Other Names:
|
Placebo Comparator: Polyethylene Glycol Ointment [Placebo]
Treatment arm or active comparator [mupirocin 2% polyethylene glycol (PEG) ointment] will be compared with its placebo comparator [polyethylene glycol (PEF) in patients with a prior history of S. aureus infection.
Drug or placebo will be applied topically to nares and/or wounds twice daily for 14 days at 3 month intervals for up to 18 months
|
The impact of the treatment arm versus placebo arm on development of S. aureus re-infections will be assessed as the primary end point.
Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Re-infection With S. Aureus
Time Frame: 18 months
|
During the study, patients with prior well-documented infections with Staphylococcus aureus who developed new signs and symptoms of infection, met standardized clinical criteria for infection, and had S. aureus isolated on culture were considered to have re-infection with S. aureus.
The number of S. aureus re-infections were compared in the mupirocin ointment (Treatment Arm) versus polyethylene glycol ointment (Placebo Arm) for all participants enrolled in the study and in participants who completed each study time point (visit)
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acquisition of New S. Aureus Strains
Time Frame: 18 months
|
In the Mupirocin Ointment (Treatment) and Polyethylene Glycol (Placebo) Arms, S. aureus isolates (MSSA or MRSA) that caused infection prior to enrollment in the study were compared with S. aureus infecting isolates (MSSA or MRSA) that occurred during the study (re-infections).
Infecting isolates that were found to be MRSA at enrollment and MRSA during the study were considered to be the same strain; this same strain definition was also applied to MSSA isolates.
Infecting isolates that changed from MRSA at enrollment to MSSA during the study (or vice versa) were considered to be different strains.
|
18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
S. Aureus Re-infections (New or Recurrent)
Time Frame: 18 months
|
The anatomic site of each S. infection at enrollment and S. aureus re-infection that occurred during the study was compared.
S. aureus isolated from a different site of infection than at baseline was considered to represent a new infection.
Isolation of S. aureus from the same site as the baseline infection was considered to represent a recurrent infection.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Suzanne Bradley, MD, VA Ann Arbor Healthcare System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
April 14, 2005
First Submitted That Met QC Criteria
April 14, 2005
First Posted (Estimate)
April 15, 2005
Study Record Updates
Last Update Posted (Estimate)
April 16, 2014
Last Update Submitted That Met QC Criteria
March 20, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Infections
- Communicable Diseases
- Staphylococcal Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Mupirocin
Other Study ID Numbers
- CLNB-001-04S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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